BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT

    MDR report key: 2872213 · Received December 13, 2012

    Report

    Report Number
    3005075853-2012-05633
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 9, 2012
    Report Date
    December 4, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RETURNED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE KNIFE FUNCTION AS INTENDED AND WITHOUT ANY DIFFICULTIES NOTED. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN AUTOMATED VISION SYSTEM, AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE STAPLE LINE WAS SUPPORTED BY HAND STITCHING THE ANASTOMOSIS AND COMPLETE THE CASE. THE CASE WAS A SUCCESS AND THE PATIENT DID WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLECTOMY PROCEDURE, THE DEVICE WAS BEING USED TO RESECT THE BOWEL. THE DEVICE WAS USED SUCCESSFULLY THREE TIMES, HOWEVER, ON THE FOURTH FIRING; IT JAMMED DURING THE RETURN PHASE OF THE FIRING SEQUENCE. THE BOWEL WAS INITIALLY TRAPPED INSIDE THE DEVICE AS THE BLADE WAS JAMMED HALF WAY ACROSS THE AREA BEING STAPLED. THEY WERE ABLE TO ADJUST THE BOWEL AND HAND STITCHED THE ANASTOMOSIS TO COMPLETE THE CASE. THE CASE WAS A SUCCESS AND THE PATIENT DID WELL. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4CC3E

    Patients

    Seq Age Sex Outcome Treatment
    1